Europe GAMP Data Integrity Conference, 4-5 October, Copenhagen, Denmark

GAMP®: Data Integrity and Computerised Solutions Innovation; A Risk-Based Approach to Compliance

Global regulatory authorities concerns are growing regarding the reliability of records and data against which product quality and patient safety decisions are made.  This is demonstrated through Data Integrity guidance publications from the UK MHRA, World Health Organisation (WHO), and US FDA, coupled with numerous regulator citation highlights.

2016 ISPE GAMP® Data Integrity Europe Conference will examine the multi-faceted risks to data integrity, including corporate pressures and incentives, human behaviours, and inadequate process and system controls.

We are excited to have assembled a world-class programme counting global speakers from regulatory authorities, industry, service providers, academia, and users of critical records and data.  The 2016 ISPE GAMP Date Integrity Europe Conference will examine all aspects of data integrity incorporating the human factor, business processes and technical controls.  The programme will also address data integrity challenges throughout the product lifecycle with sessions relating to clinical, manufacturing, and laboratories.  The exchange between the speakers and attendees, as well as an impressive location, promise to be interactive, innovative, and educational.

In addition, GAMP, an ISPE Communities of Practice, is Celebrating 25 Years of Innovative Good Practice in 2016 and will be celebrating this significant milestone at this conference. 

We look forward to welcoming you to Copenhagen to participate in the 2016 ISPE GAMP Data Integrity Europe Conference!

Why Attend?

  • Understand the implications of data integrity risks to your organisation
  • Hear the concerns and expectations of industry regulators in relation to data integrity
  • Experience innovative and pragmatic solutions that addresses the multi-faceted dimensions of data integrity risks throughout the product lifecycle
  • Interact with industry thought leaders to share your own challenges and receive pragmatic, risk based advice
  • Celebrate GAMP® 25 years!

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